aJit Synopsis

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SYNOPSIS

COMPLICATIONS AND

MANAGEMENT OF HAND

INFECTIONS

SYNOPSIS SUBMITTED FOR APPROVAL BY ETHICAL

COMMITTEE BY

DR. AJIT MISHRA

FOR BRANCH MS (GENERAL SURGERY)

DOCUMENTS FOR DISSERTATION


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CHECK-LIST ENCLOSURES (DISSERTATIONS)

For submission of Research proposal to

Ethics Committee of B.J.M.C. and S.G.H. Pune

1] Cover Page (Appendix 1)

2] Check-List Enclosures (Dissertations)

1. Research Proposal (Appendix 2)

1. a Part IGeneral Information

1. b Part IIOne page executive summary sheet

1.c Part III - Details of Research Proposal2. Inform Consent (Appendix 3)

2. a English

2. b Marathi

2. c Hindi

3. Application for Permission for Animal Experiments

(Appendix 4)

4. PI undertaking (Appendix 5)5. Certificate from HOD (Appendix 6)

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Research proposal should be submitted inA) Hard copy: i. e. PrintoutsOne Copy only

B) Soft Copy: On C D /DVD;Preferably in *.pdf format

OR in Word document format

Appendix 1:


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Cover Page (for Dissertations)



1.Full Name of PG Student:

Dr. MISHRA AJIT MATAPRASAD

2.Department: SURGERY

3.Candidate admitted in the year: 2011

4.Course and subject: SURGERY

5.College Name & Address:

B.J.MEDICAL COLLEGE, PUNE.

6 Title of Research Project topic:COMPLICATIONS AND MANAGEMENT OF

HAND INFECTIONS

7. Full name of P.G. Guide :Dr. SHAILAJA P.

JADHAV

8. Contact phone number of PG Student: 9324381753


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Appendix 2:

Research Proposal

For submission of Research proposal toEthics Committee of B.J.M.C. and S.G.H. Pune

PART I : GENERAL INFORMATION

1. TITLE OF THE PROJECT :COMPLICATIONS AND MANAGEMENT OF

HAND INFECTIONS

2. NAME AND DESIGNATION OF :

a) Postgraduate Guide:DR.SHAILAJA P. JADHAVPROFESSORDEPT OF SURGERY


b) Postgraduate Student:

Dr. MISHRA AJIT MATAPRASADRESIDENT

DEPT OF SURGERY


3. DURATION OF THE PROJECT :

a) Period that may be required for data collection : 2 YEARb) Deadline for collecting data : JUNE2013

c) Period that may be required for analysis of data : 6 MONTHSd) Deadline for analysis of data : DEC 2013

4. DEADLINE FOR SUBMISSION OF THE


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DISSERTATION TO THE UNIVERSITY : DEC 2013

5. REVIEW OF PROGRESS :

Reviews 1st

quarter 2nd

quarter 3rd

quarter

Review of progress of

project

Review of collection of

data

Review of analyzed data

6. SIGNATURES :


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a) Postgraduate student :

b) Postgraduate guide :

c) Head of dept,Dept of surgery,B.J.Medical college, pune.

d) Head of dept,Dept of Radiodiagnosis,,

B.J.Medical college, pune

e) Head of dept ,

Dept of surgery,B.J.Medical college, pune

7. a) Date of submission to ethical committee :

b) Date of clearance of the committee:

c) Remarks of the secretary:

PART II :ONE PAGE EXECUTIVE SUMMARY SHEET


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1) Title of the Project:- COMPLICATIONS AND MANAGEMENT OF

HAND INFECTIONS

2) Name of the PG guide:- DR. SHAILAJA P. JADHAV

3) Name of the PG Student:- DR. MISHRA AJIT MATAPRASAD

4) Name of the Department:- SURGERY

5) Name of the Institute:- B.J.MEDICAL , PUNE.

6) Aims & Objectives:-

Early diagnosis and management of various hand infections

Early detection of complications of hand infections andtheir management

Preserve optimal function of hand following infection

7) Introduction:.

Few structures of the body are as complex or as unique as

the human hand with the functions of sensation, mobility,and strength in one small area. The hand consists of multiple

compartments and planes, the knowledge of which allows

one to understand the pathophysiology, diagnosis, and

treatment of hand infections The hands compartmentalized

anatomy is one of the reasons why the hand is more prone to

infections.

Seemingly simple infections of the hand can more often

result in debilitating conditions and significant morbidity.

The hand being one of the more important functional organs

required in day to day physical activities, it becomes

important that such morbid conditions should be diagnosed


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and treated effectively at an early stage so that the function of the

hand can be well preserved. If an infection is not appropriately

diagnosed and treated, significant morbidity can result.

8) Material & Methods:-

Sample size- All cases admitted between period June 2011June 2014

Number of cases- 25

Type of study- Prospective

Duration of study:- 2 years

9) Risks Involved:- This is not an interventional study so complications related toprocedure and anesthetic complications are the only risk involved in this study.

PART III : DETAILS OF RESEARCH PROPOSAL

1. TITLE OF THE PROJECT : COMPLICATIONS AND

MANAGEMENT OF HAND INFECTIONS

2. AIMS AND OBJECTIVES

Early diagnosis and management of various hand infections

Early detection of complications of hand infections and

their management

Preserve optimal function of hand following infection


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3. INTRODUCTION (Background information)

Few structures of the body are as complex or as unique as the human

hand with the functions of sensation, mobility, and strength in one

small area. The hand consists of multiple compartments and planes,the knowledge of which allows one to understand the

pathophysiology, diagnosis, and treatment of hand infections The

hands compartmentalized anatomy is one of the reasons why the

hand is more prone to infections.

Seemingly simple infections of the hand can more often result in

debilitating conditions and significant morbidity. The hand being one

of the more important functional organs required in day to day

physical activities, it becomes important that such morbid conditionsshould be diagnosed and treated effectively at an early stage so that

the function of the hand can be well preserved. If an infection is not

appropriately diagnosed and treated, significant morbidity can result.

A thorough understanding of hand and finger anatomy and

knowledge of the bacteria commonly involved in infections of the

upper extremity are required of the surgeon who will be caring for

these patients. An understanding of the fascial boundaries of thehand will help to identify the extent of the infection and plan surgical

incisions.

Host factors, location, and circumstances of the infection are

important guides to initial treatment strategies. Many hand infections

improve with early splinting, elevation, appropriate antibiotics and, if

an abscess is present, incision and drainage..

4. MATERIAL & METHODS

Sample size-All cases admitted between period June 2011 June

2013

Number of cases -25


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Type of study- Prospective

Duration of study:-2 years

5.

DETAILED RESEARCH PLAN

(Groups / Procedures etc)

Patients will be selected according to the selection criterion i.e- All patients belonging to all age groups having hand infections will be

included in the study.

Selected patients will be evaluated by- Proper history

- clinical examination

- Investigations

Plan of the study-

All patients coming to the casualty and outdoor patient department with

non specific complaints associated with hand infections such as pain,

swelling, redness, pus and discharge will be evaluated. One important

aspect of this study will be follow up of these patients.

Various conditions that will be considered in this study are:

1)Paronychia

2)Herpetic whitlow

3)Felon

4)Tenosynovitis

5)Secondary infections of post traumatic crush injuries.

6)Cellulitis

7)Infections of the joint spaces, web spaces and palmar spaces

The aim of this study will be early diagnosis and treatment of hand

infections. This is important as more often than not hand infections


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go undiagnosed and are associated with significant morbidity and

devastating complications such as stiffness, contractures and

amputation.

One important life threatening condition is necrotizing fasciitiswhich because of its spreading nature requires early diagnosis and

early surgical management.

A detailed understanding of the anatomy of the hand is essential

for the appropriate surgical management of hand infections. This

includes the following:

1)bones and joints2)skin

3)palmar spaces

4)muscles and tendons

One of the most common causes of hand infections is penetrating

trauma which introduces various organisms most common ones

being staphylococci and streptococci. In immunocompromisedconditions and diabetes mellitus gram negative and anaerobic

organisms have also been implicated.

Patients will be evaluated under the following criteria:

1)history2)clinical findings- local and systemic findings3)laboratory investigations blood culture, blood sugar levels,

blood counts

4)gram staining, anaerobic cultures to identify the causativeorganisms.

5)Radiological investigations such as x-rays to rule outinvolvement of bones and joints and to exclude fractures and

foreign body.


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Management:

Goal of treatment of hand infections is rapid and full recovery of

function as well as prevention of complicationsManagement includes:

1)Conservative management2)Active surgical mangement

Conservative line of management is usually adopted in the early

stages of the disease when the infection has been diagnosed 24-48

hours after the onset.

It includes:

1)Splinting2)Elevation of limb3)Moist heat to the affected part4)Systemic antibioticsoral or intravenous

Following conservative treatment, follow up of the patient will be

done. Decrease in presenting symptoms will be indicative of

effectiveness of conservative treatment while increase in

symptoms and local skin changes(increased swelling, redness,tenderness, pus discharge)will be indicative of failure of

conservative treatment thus compelling the need for active surgical

treatment.

Surgical treatment is considered when conservative means fail to

control the infection.

1)Open drainage

2)Debridement

Thus in conclusion, my study aims at treating hand infections at an

early stage so that the optimal function of the hand can be

preserved. Complications include septicemia, gangrene,

contractures, amputation of the involved limb.


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6. SELECTION OF CASES (Inclusion & Exclusion Criteria)

Case selection (Inclusion criterion)

All patients having hand infections.

7. CASE RECOD FORMS :-

1. Name2. Age3. Sex4. Address5. Occupation6. Religion7. Chief complaints8. History

9. Past history

10.Any trauma related history

11.Any other relevant past surgical procedure performed

General examination

Temperature

Pulse

Respiration

Blood pressure


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Respiratory rate

Weight

Pallor\ icterus\ cyanosis\clubbing

Lynphadenopathy \edema

C.V S examination

Respiratory system examination

C.N S examination

Examination for cervical spine and thoracic outlet syndrome

Examination of distal circulation(radial and ulnar pulsation)

9. PARAMETERS :

Routine lab Investigations

- Hb

- BT/CT

- Urine examination

- Blood sugar

- Renal profile

- Liver profile

- HIV and HbSAg testing

Radiological investigations

- X-ray

- Ultrasound

- MRI

10 FACILITIESAVAILABLE:

- O.T for surgery


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- Basic surgical instruments

12. REQUIREMENTS :

- O.T for surgery

- Basic surgical instruments

13.REFERENCES :

1. Hausman MR, Lisser SP. Hand infections. Orthop Clin North Am. 1992;23:17185.

2. Nathan R, Taras JS. Common infections in the hand. In: Hunter JM, Mackin E, Callahan AD, eds. Rehabilitation of

the hand: surgery and therapy. 4th ed. St. Louis: Mosby, 1995:25160.

3. Moran GJ, Talan DA. Hand infections. Emerg Med Clin North Am. 1993;11:60119.

4. Brown DM, Young VL. Hand infections. South Med J. 1993;86:5666.

5. Krieger LE, Schnall SB, Holtom PD, Costigan W. Acute gonococcal flexor

tenosynovitis. Orthopedics. 1997;20:64950.

6. Schaefer RA, Enzenauer RJ, Pruitt A, Corpe RS. Acute gonococcal flexor tenosynovitis in an adolescent male

with pharyngitis. A case report and literature review. Clin Orthop. 1992;281:2125.

7. Townsend DJ, Singer DI, Doyle JR. Candida tenosynovitis in an AIDS patient: a case report. J Hand Surg

[Am]. 1994;19:2934.

8. Gunther SF, Gunther SB. Diabetic hand infections. Hand Clin. 1998;14:64756.

9. Bhatty MA, Turner DP, Chamberlain ST. Mycobacterium marinumhand infection: case reports and review of

literature. Br J Plast Surg. 2000;53:1615.

10. Gomperts BN, White LK. Gonococcal hand abscess. Pediatr Infect Dis J. 2000;19:6712.

11. Rockwell PG. Acute and chronic paronychia. Am Fam Physician. 2001;63:11136.

12. Jebson PJ. Infections of the fingertip. Paronychias and felons. Hand Clin. 1998;14:54755.

13. Roberge RJ, Weinstein D, Thimons MM. Perionychial infections associated with sculptured nails. Am J Emerg

Med. 1999;17:5812.

14. Harrison BP, Hilliard MW. Emergency department evaluation and treatment of hand injuries. Emerg Med Clin

North Am. 1999;17:793822.

15. Stern PJ. Selected acute infections. Instr Course Lect. 1990;39:53946.

16. Watson PA, Jebson PJ. The natural history of the neglected felon. Iowa Orthop J. 1996;16:1646.


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17. Connolly B, Johnstone F, Gerlinger T, Puttler E. Methicillin-resistant Staphylococcus aureusin a finger

felon. J Hand Surg. 2000;25:1735.

18. Karanas YL, Bogdan MA, Chang J. Community acquired methicillin-resistant Staphylococcus aureushand

infections: case reports and clinical implications. J Hand Surg. 2000;25:7603.

19. Mohler A. Herpetic whitlow of the toe. J Am Board Fam Pract. 2000;13:2135.

20. Crumpacker CS. Herpes simplex. In: Freedberg IM, Fitzpatrick TB, eds. Fitzpatrick s Dermatology in general

medicine. 5th ed. New York: McGraw-Hill, 1999:2414

26.

21. Schwandt NW, Mjos DP, Lubow RM. Acyclovir and the treatment of herpetic whitlow. Oral Surg Oral Med Oral

Pathol. 1987;64:2558.

22. Gill MJ, Arlette J, Buchan K, Tyrrell DL. Therapy for recurrent herpetic whitlow. Ann Intern

Med. 1986;105:631.

23. Laskin OL. Acyclovir and suppression of frequently recurring herpetic whitlow. Ann Intern Med. 1985;102:494

5.

24. Boles SD, Schmidt CC. Pyogenic flexor tenosynovitis. Hand Clin. 1998;14:56778.

25. Kanavel AB. Infections of the hand. Aguide to the surgical treatment of acute and chronic suppurative processes

in the fingers, hand, and forearm.7th ed. Philadelphia: Lea & Febiger, 1939.

26. Neviaser RJ. Tenosynovitis. Hand Clin. 1989;5:52531.

27. Schnall SB, Vu-Rose T, Holtom PD, Doyle B, Stevanovic M. Tissue pressures in pyogenic flexor

tenosynovitis of the finger: compartment syndrome and its management. J Bone Joint Surg [Br]. 1996;78:793

5.

28. Cardinal E, Bureau NJ, Aubin B, Chhem RK. Role of ultrasound in musculoskeletal infections. Radiol Clin

North Am. 2001;39:191201.

29. Lille S, Hayakawa T, Neumeister MW, Brown RE, Zook EG, Murray K. Continuous postoperative catheter

irrigation is not necessary for the treatment of suppurative flexor tenosynovitis. J Hand Surg. 2000;25B:3047.

30. Griego RD, Rosen T, Orengo IF, Wolf JE. Dog, cat, and human bites: a review. J Am Acad

Dermatol. 1995;33:101929.

31. Kelleher AT, Gordon SM. Management of bite wounds and infection in primary care. Cleve Clin J

Med. 1997;64:13741.

32. Perron AD, Miller MD, Brady W J. Orthopedic pitfalls in the ED: fight bite. Am J Emerg Med. 2002;20:1147.

33. Patzakis MJ, Wilkins J, Bassett RL. Surgical findings in clenched-fist injuries. Clin Orthop. 1987;220:23740.

34. Dellinger EP, Wertz MJ, Miller SD, Coyle MB. Hand infections. Bacteriology and treatment: a prospective

study. Arch Surg. 1988;123:745

50.

35. Zubowicz VN, Gravier M. Management of early human bites of the hand: a prospective randomized

study. Plast Reconstr Surg. 1991;88:1114.

36. Medeiros I, Saconato H. Antibiotic prophylaxis for mammalian bites (Cochrane Review). Cochrane Database

Syst Rev. 2003;2:CD001738.

37. Louis DS, Jebson PJ. Mimickers of hand infections. Hand Clin. 1998;14:51929.

38. Matsui T. Acute nonspecific flexor tenosynovitis in the digits. J Orthop Sci. 2001;6:2347.

NAME AND SIGNATURE OF POSTGRADUATE STUDENT

(DR MISHRA AJIT MATAPRASAD):

NAME AND SIGNATURE OF POSTGRADUATE GUIDE


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(DR SHAILAJA P JADHAV):

PROFESSOR AND HEAD,

DEPARTMENT OF SURGERY

B. J. MEDICAL COLLEGE, PUNE.

Appendix 3:

INFORMED CONSENT FORM

For submission of Research proposal toEthics Committee of B.J.M.C. and S.G.H. Pune

1. I, Mr./ Mrs. ____________________________________, age ______ yearsresiding at

_________________________________________________________________

hereby give my informed consent to participate in COMPLICATION AND

MANAGEMENT OF HAND INFECTIONS project..

2. There is no compulsion on me to participate in this project and I am giving my

free consent for it.

3. I am ready and willing to undergo all tests and treatments in the present project.

4. I have read and I have been explained the general information and purpose of thepresent project.


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5. I have been informed / I have read the probable complications while participating

in the present project.

6. I know that I can withdraw from the present project at any time.

7. Any data or analysis of this project will be purely used for scientific purpose andmy name will be kept confidential except when required for any legal purpose.

8. I can read English / I can understand data read out to me in English.

Signature 0f VolunteerSignature of parent/Guardian in caseOf minor person.

Witnesses:

1.

2.

Signature of Principal Investigator.


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APPENDIX 5:

UNDERTAKING BY THE INVESTIGATOR



1] Full name, address and title of the Principal Investigator

Dr. SHAILAJA P JADHAVPROFESSORDEPT OF SURGERY

B.J.MEDICAL COLLEGE, PUNE

2] Name and address of the medical college, hospital or other facility where the

clinical trial will be conducted: Education, training & experience that qualify

the Investigator for he clinical trial (Attach details including Medical

Council registration number, and /or any other statement(s) of

qualification(s)

Dr. MISHRA AJIT MATAPRASADRESIDENTDEPT OF SURGERY



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3] Name and address of all clinical laboratory facilities to be used in the study.

4] Name and address of the Ethics Committee that is responsible for approval

and continuing review of the study.

B.J.M.C. SGH, Pune

5] Names of the other members of the research team (Co-or sub-

Investigators) who will be assisting the Investigator in the conduct of the

investigation(s).

6] Protocol Title and study number (if any) of the clinical trial to be conductedby the Investigator.

7] Commitments

i. I have reviewed the clinical protocol and agree that it contains all the

necessary information to conduct the study. I will not begin the

study until all necessary Ethics Committee and regulatory approvals

have been obtained.

ii. I agree to conduct the study in accordance with the current protocol.

I will not implement any deviation from or changes of the protocol

without agreement by the Sponsor and prior review and documented

approval/favorable opinion from the Ethics Committee of the

amendment, except where necessary to eliminate an immediate

hazard(s) to the trial Subjects or when the change(s) involved are

only logistical or administrative in nature.

iii. I agree to personally conduct and/or supervise the clinical trial at my

site.


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iv. I agree to inform all Subjects that the drugs are being used for

investigational purposes and I will ensure that the requirements

relating to obtaining informed consent and ethics committee review

and approval specified in the GCP guidelines are met.

v. I agree to report to the Sponsor all adverse experiences that occur in

the course of the investigation(s) in accordance with the regulatory

and GCP guidelines.

vi. I have read and understood the information in the Investigators

broacher, including the potential risks and side effects of the drug.

vii. I agree to ensure that all associates, colleagues and employees

assisting in the conduct of the study are suitably qualified and

experienced and they have been informed about their obligations in

meeting their commitments in the trial.

viii. I agree to maintain adequate and accurate records and to make

those records available for audit/inspection by the Sponsor, Ethics

Committee, Licensing Authority or their authorized representatives,

in accordance with regulatory and GCP provisions; I will fully

cooperate with any study related audit conducted by regulatory

officials or authorized representatives of the Sponsor.

ix. I agree to promptly report to the Ethics Committee all changes in the

clinical trial activities and all unanticipated problems involving risks

to human subjects or others.

x. I agree to inform all unexpected serious adverse events to the

Sponsor as well as the Ethics Committee within seven days of their

occurrence.


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xi. I will maintain confidentiality of the identification of all participating

study patients and assure security and confidentiality of study data.

xii. I agree to comply with all other requirements, guidelines and

statutory obligations as applicable to clinical investigators

participating in clinical trails.

8] Signature of Investigators with Name and Date.

Investigators Name Signature Date

Principal Investigator

Co-Investigator 1

Co-Investigator 2


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Appendix 6:

CERTIFICATE from HOD



Date:

This is to certify that Research Protocol entitled

COMPLICATION AND MANAGEMENT OF

HAND INFECTIONS

Has been presented, discussed and modified accordingly.

Further it is stated that to the best of my knowledge there is no

ethical dispute in this research protocol and therefore may be

approved by the Ethics Committee, B. J. Medical College &

Sassoon General Hospitals, and Pune.

Signature


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